Headache DisordersNCT03330639
Capsaicin in Treatment of Rhinogenic Headache
A study testing Capsaicin in people with Headache Disorders, run by University of Nebraska.
Trial summary
Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2020to 23 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors.
Who cannot join
- Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.
About this study
Official title: The Role of Topical Capsaicin in Treatment of Rhinogenic Headache
Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution of the sinonasal cavity. This study is a randomized, double-blinded, parallel trial.
Read the detailed description
- Title: The role of capsaicin in treatment of rhinogenic headache
- Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution.
- Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit.
- Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.
- Conditions
- Headache Disorders
- Being tested
- Capsaicin, Placebo
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinOther
Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA.
PlaceboOther
This group will receive the saline placebo solution.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group will receive the capsaicin. The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter. Receives: Other: Capsaicin |
| Placebo Group | Placebo comparator | This group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache medication use
We will track the amount of headache medication used during the study period
Measured: 1 year
Secondary outcomes (2)
number of patients with treatment related adverse events
patients will be asked to report any adverse reactions or events during the study period.
Measured: 1 year
headache frequency and severity
Patient will be asked to record the number of headaches during the study period, and record the severity from 1-10 on the Visual Analog Scale (VAS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Jun 2020
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Why it stopped: Grant funding for study was not obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christie Barnes, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330639
- Sponsor's protocol ID
- 0511-17-FB
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2017
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gevorgyan A, Segboer C, Gorissen R, van Drunen CM, Fokkens W. Capsaicin for non-allergic rhinitis. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010591. doi: 10.1002/14651858.CD010591.pub2.
PubMed 26171907
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Topical Capsaicin in Treatment of Rhinogenic Headache
- ClinicalTrials.gov ID
- NCT03330639
- Acronym / sponsor ID
- 0511-17-FB
- Conditions
- Headache Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant funding for study was not obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution of the sinonasal cavity. This study is a randomized, double-blinded, parallel trial.
Detailed description
- Title: The role of capsaicin in treatment of rhinogenic headache
- Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution.
- Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit.
- Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized parallel group
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: CapsaicinThis group will receive the capsaicin. The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter. |
| Placebo Group | Placebo comparator | Other: PlaceboThis group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors.
Key exclusion criteria (1 listed)
- Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsaicinCapsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA. | Other | Experimental Group |
| PlaceboThis group will receive the saline placebo solution. | Other | Placebo Group |
Primary outcome
headache medication use
Time frame: 1 year
We will track the amount of headache medication used during the study period
2 secondary outcomes
number of patients with treatment related adverse events
Time frame: 1 year
headache frequency and severity
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 26171907Gevorgyan A, Segboer C, Gorissen R, van Drunen CM, Fokkens W. Capsaicin for non-allergic rhinitis. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010591. doi: 10.1002/14651858.CD010591.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christie Barnes, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin in people with Headache Disorders, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache medication use (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.